California State University, San Bernardino

Administrative Use Only IBC/BUA Number NIH Recombinant Biosafety Approval DNA Designation Level Date IBC/BUA#

California State University, San Bernardino Biological Use Authorization Application Institutional Biosafety Committee

Instructions for completing the Biological Use Authorization Application shall be read prior to completing this application and applicable attachments. Submit a signed hard copy of the completed application to CSUSB Research Compliance Officer, AR-111 and an electronic copy to [email protected]. If more space is needed please attach a separate sheet. If you need assistance in completing the form refer to or contact the Research Compliance Officer, Michael Gillespie at (909) 537-7588.

Project Title:

Faculty Name: Dept: Date:

Research Collaborators (including students) (list all):

This research is subject to annual review and renewal.

SECTION 1: RESEARCH DESCRIPTION

Describe in two or three paragraphs the work to be conducted in your laboratory directly related to rDNA (include general experimental procedures and any microbial, parasitic etc. agents involved):

SECTION 2: CHECK AND IDENTIFY AS APPLICABLE TO THE RESEARCH DESCRIBED ABOVE

Use of Recombinant DNA

Confined to microbial environment, in laboratory

Intentional release to environment

Transgenic Animals, identify

Transgenic Plants, identify

Other; specify

Use of Microbial/Infectious Agents Viruses, identify: Bacteria, identify: Fungi, identify: Prions, identify: Parasitic Agents, identify: Pre-exposure immunization required:

Use of Animals

Invertebrates, identify: Vertebrates, identify: IACUC Protocol #: Use of infectious agents in animals Use of animals that are potential reservoirs of zoonotic diseases

Use of Human Cells, Blood, or Fluid

Use of human cell lines: identify cell line and source Use of human stem cells: identify cell type and source Use of primary human cells: identify cell type Use of human blood: identify source (purchase or collection) Use of human fluid: identify source (purchase or collection)

Have you obtained IRB approval? IRB Protocol #: What procedures will you use to reduce transmission of potential human pathogens (PPE, testing of samples)?

SECTION 3: USE OF RECOMBINANT DNA (rDNA)

Provide the following information for the use of rDNA: a) Nature of inserted DNA sequence, including the species of origin, gene product and function (if known): b) Source of DNA: Commercial source (give name of company): Developed in lab: From another research lab (give name and prepare MTA): c) Host(s) and vector(s) to be used: d) Will an attempt be made to express the foreign gene? Yes No

SECTION 4: RISK ASSESSMENT AND RISK GROUP (RG)

Check the Risk Group (RG) of the agent (bacteria, virus etc.) being used. (For Risk Group classification go to page 6 of this document.) RG1 RG2 RG3 RG4 No bacterial, viral, parasitic etc. agent will be used

SECTION 5: PHYSICAL CONTAINMENT AND BIOLOGICAL SAFETY LEVEL (BSL)

Check the BSL of the agent (bacteria, virus etc.) being used. (For Biological Safety Level classification go to page 7 of this document.)

Exempt BSL-1 BSL-2 BSL-3 Practices/BSL-2 Facility BSL-3

If you created a transgenic animal or plant, what special measures will you take to ensure its containment?

SECTION 6: LOCATIONS FOR USE AND STORAGE OF INFECTIOUS AGENTS AND rDNA

List the location(s) where work will be conducted and where materials will be stored.

Building Room Number

Does this project involve CSUSB-managed funds for the use of rDNA at a site other than CSUSB? Yes No

If yes, please list the site(s) here:

SECTION 7: CONTAINMENT/SAFETY PROCEDURES Read the standard practices and physical containment procedures as defined for your BSL level in Appendix G of the NIH Guidelines. Do you agree to abide by these guidelines with respect to standard procedures and physical containment?

Yes No SECTION 8: DISPOSAL OF CONTAMINATED MATERIALS

Do you agree to dispose of all contaminated materials according to the CSUSB Biohazard Control Program (decon first via autoclave, chlorox etc. as appropriate; sharps into sharps containers; BSL 2 waste into designated red biohazardous waste containers etc.)?

Yes No

SECTION 9: TRAINING OF PERSONNEL

Describe how personnel have been trained in the handling of agents to be used (e.g. hands on training in the lab, lab meeting etc.).

SECTION 10: ACCIDENTAL EXPOSURE

Do you agree to contact CSUSB Environmental Health and Safety (909-537-5179) immediately in the event an employee, student, or coworker becomes ill and/or exhibits symptoms and signs consistent with an infection by an organism used in this research?

Yes No

Annual Renewals: Have there been any adverse events related to work with this organism over the past year? Yes No

If yes, please describe:

DEPARTMENTAL APPROVAL

The Department Chair/Director must read the protocol and sign below indicating department approval before IBC review may occur. Note: If the Department Chair/Director is an investigator on this application, this approval must be obtained from the next highest level of administrative authority.

I hereby confirm that I have read the Protocol Narrative and can certify that: 1) the research is appropriate in design; 2) the investigator (or faculty sponsor) is competent to perform (or supervise) the study; and 3) there are sufficient funds available to support performance of this research. My signature below denotes Departmental Approval of this study as submitted.

Name Signature Date signed Department Chair/Director Department Chair/Director (I understand that by typing in my name above serves as my legal signature for this study). INVESTIGATOR'S ASSURANCE California State University, San Bernardino Institutional Biosafety Committee

1. All persons conducting this work (including my collaborators) have completed the CSUSB Safety Program Training and have received instruction on the specific hazards associated with the work and the specific safety equipment, practices, and behaviors required during the course of the work and use of these facilities.

2. Any spill of biohazardous material, any equipment or facility failure (e.g., ventilation failure), and/or any breakdown in procedure that could result in potential exposure of laboratory personnel and/or the public to biohazardous material will be reported to CSUSB Environmental Health and Safety (909-537-5179) immediately.

3. Any proposed changes in my work that would result in an increased level of biohazard will be reported to the IBC before the change is implemented.

4. No work that requires IBC approval prior to initiation will be initiated or modified until approval is received from the IBC.

5. If this project involves rDNA molecules, I have read and understand my responsibilities as Principal Investigator outlined in Section IV-B-4 of the NIH Guidelines, and will comply with these responsibilities.

6. I certify that the information provided within this application is accurate to the best of my knowledge. I also understand that, should I use the project described in this application as a basis for a funding proposal (either intramural or extramural), it is my responsibility to ensure that the description of the work in the funding proposal is identical in principle to that contained in this application.

7. I certify that all work on this project will be performed in accordance with all policies and procedures of the CSUSB Safety Program and in accordance with NIH guidelines as appropriate for the risk group and BSL of the agents involved.

Name of Lead Researcher

Signature of Lead Researcher

(I understand that by typing in my name above serves as my legal signature for this study).

NIH Recombinant DNA Guidelines (USA, 2002) April 2002. Appendix B. http://oba.od.nih.gov/rdna/nih_guidelines_oba.html

Risk Group 1 (RG1): Agents that are not associated with disease in healthy adult humans. Includes a list of animal viral etiologic agents in common use.

Risk Group 2 (RG2): Agents that are associated with human disease which is rarely serious and for which preventive or therapeutic interventions are often available.

Risk Group 3 (RG3): Agents that are associated with serious or lethal human disease for which preventive or therapeutic interventions may be available (high individual risk but low community risk).

Risk Group 4 (RG4): Agents that are likely to cause serious or lethal human disease for which preventive or therapeutic interventions are not usually available (high individual risk and high community risk). Summary of Recommended Biological Safety Levels for Infectious Agents

BSL Agents Practices Primary Barriers Facilities and (Secondary Safety Equipment Barriers) 1 Not known to Standard microbiological No primary barriers Laboratory bench and consistently cause practices required. sink required diseases in healthy PPE: laboratory coats adults and gloves; eye, face protection, as needed 2 Agents associated with Primary barriers: BSL-1 plus: BSL-1 practice plus: human disease - BSCs or other physical - Autoclave available - Limited access Routes of transmission containment devices - Biohazard warning include percutaneous used for all signs injury, ingestion, mucous manipulations of agents - “Sharps” precautions membrane exposure that cause splashes or - Biosafety manual aerosols of infectious defining any needed materials waste decontamination or medical surveillance policies PPE: Laboratory coats, gloves, face and eye protection, as needed 3 Indigenous or exotic BSL-2 practice plus: Primary barriers: BSL-2 plus: agents that may cause - Controlled access - BSCs or other physical - Physical separation serious or potentially -Decontamination of all containment devices from access corridors lethal disease through waste used for all open - Self-closing, double- the inhalation route of -Decontamination of manipulations of agents door access exposure laboratory clothing - Exhausted air not before laundering recirculated PPE: Protective - Negative airflow into laboratory clothing, laboratory gloves, face, eye and - Entry through airlock or respiratory protection, as anteroom needed - Hand washing sink near laboratory exit 4 Dangerous/exotic agents BSL-3 practices plus: Primary barriers: BSL-3 plus: which post high - Clothing change before - All procedures - Separate building or individual risk of aerosol- entering conducted in Class III isolated zone transmitted laboratory - Shower on exit BSCs or Class I or II - Dedicated supply and infections that are - All material BSCs in combination exhaust, vacuum, and frequently fatal, for decontaminated on exit with full-body, air- decontamination which there are no from facility supplied, positive systems vaccines or treatments pressure suit - Other requirements Agents with a close or outlined in the text in identical antigenic BMBL 5th Ed. relationship to an agent requiring BSL-4 until data are available to redesignate the level Related agents with unknown risk of transmission

From Section IV—Laboratory Biosafety Level Criteria Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition Available at: http://www.cdc.gov/biosafety/publications/bmbl5/